Sudden Cardiac ArrestACE-PASNCT05135403
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
An observational study of Sudden Cardiac Arrest, run by Kestra Medical Technologies, Inc. at 1 site in United States.
Trial summary
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Arrest
- What is being tested?
- Defibrillation
- Type of treatment
- Medical device
- How many people
- 5,179 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 1 Oct 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.
Who may be able to join
- Adult patient prescribed the ASSURE wearable cardioverter defibrillator
- Provided written informed consent to participate in the ASSURE Patient Registry
Who cannot join
- Patients who do not meet the Inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98033
Kristin Eis, BSChE, MBA, 12069636044, kristin.eis@kestramedical.com
About this study
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
- Conditions
- Sudden Cardiac Arrest
- Being tested
- Defibrillation
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefibrillationDevice
External defibrillation from a wearable cardioverter defibrillator
| Study group | Role | What they receive |
|---|---|---|
| ASSURE Registry Patients | Patient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant. Receives: Device: Defibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall shock conversion rate
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%
Measured: Up to 3 years
Inappropriate shocks per patient month
Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075
Measured: Up to 3 years
Secondary outcomes (2)
First shock conversion rate
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) converted with a single shock. (report only)
Measured: Up to 3 years
Inappropriate shock rate
Percent of patients who experience at least one inappropriate shock (report only)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start20 Nov 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,179 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Kestra Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeanne Poole, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135403
- Sponsor's protocol ID
- DHF-00187-01
- Acronym
- ACE-PAS
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
- ClinicalTrials.gov ID
- NCT05135403
- Acronym / sponsor ID
- ACE-PAS / DHF-00187-01
- Conditions
- Sudden Cardiac Arrest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,179 participants (estimated)
- Lead sponsor
- Kestra Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASSURE Registry Patients | – | Device: DefibrillationPatient prescribed the ASSURE WCD who have also consented to participate in the ASSURE Patient Registry. Patients include those with reduced left ventricular ejection fraction (LVEF) and recent myocardial infarction, recent coronary revascularization, or new onset heart failure (HF) to allow for optimization of medical therapy and re-evaluation of cardiac function. Additional indications include ICD explant due to infection, postponed ICD implant, and pending heart transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.
Key inclusion criteria (2 listed)
- Adult patient prescribed the ASSURE wearable cardioverter defibrillator
- Provided written informed consent to participate in the ASSURE Patient Registry
Key exclusion criteria (1 listed)
- Patients who do not meet the Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefibrillationExternal defibrillation from a wearable cardioverter defibrillator | Device | ASSURE Registry Patients |
Primary outcome
Overall shock conversion rate
Time frame: Up to 3 years
Percent of spontaneous episodes of ventricular tachycardia/ventricular fibrillation (VT/VF) successfully converted with one or more shocks ≥ 89.0%
Inappropriate shocks per patient month
Time frame: Up to 3 years
Total inappropriate shocks/cumulative months of WCD use for all patients ≤ 0.0075
2 secondary outcomes
First shock conversion rate
Time frame: Up to 3 years
Inappropriate shock rate
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeanne Poole, M.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Arrest, run by Kestra Medical Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Eis, BSChE, MBA (14256547596, kristin.eis@kestramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall shock conversion rate (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.